Long-acting HIV fusion inhibitor albuvirtide combined with ritonavir-boosted lopinavir for HIV-1-infected patients after failing the first-line antiretroviral therapy: 48-week randomized, controlled, phase 3 non-inferiority TALENT study

Su, Bin; Cheng, Yifei; Zhao, Quan; Cai, Weiping; Wang, Min; Lu, Hongzhou; Mu, Tingting; Chen, Yuanyuan; Liu, Li; Wang, Hui; He, Yun; Zheng, Yuhua; Li, Linghua; Chen, Jinfeng; Yu, Jianhua; Zhu, Biao; Zhao, Min; Sun, Yongtao; Lun, Wenhui; Zhang, Yihang; Wang, Hu; Xia, Wei; Sun, Lijun; Dai, Lili; Jiang, Taiyi; Wang, Meixia; Zheng, Qingshan; Peng, Haiyan; Wang, Yao; Hu, Min; Liu, Xia; Lü, Rui; Hu, Jianhua; Sun, Cheng-Chen; Xing, H; Shao, Yijie; Xie, Dong; Zhang, Tong; Zhang, Fujie; Wu, Hao

doi:10.1016/j.jinf.2022.05.034

Cited by 8 publications

(2 citation statements)

References 7 publications

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“…Although a decrease in heart rate was observed in 2 subjects, this nding has been observed in previous phase III study using 45-min ABT intravenous infusion (Su et al, 2022). Therefore, a decrease in heart rate was not considered speci c to the 0.5-min or 3-min injection administration.…”

Section: Discussionmentioning

confidence: 77%

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

Qin

Cheng²,

Zhang

et al. 2023

Preprint

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Purpose. Albuvirtide (ABT) is the first long-acting HIV fusion inhibitor originally developed in China, blocking the invasion of HIV-1 virus into target cells. This study aimed to compare the pharmacokinetics, tolerability, and safety of ABT following a single intravenous (IV) bolus injection or intravenous drip in healthy Chinese subjects.Methods. A single-center, randomized, open-label, single-period, parallel phase I clinical trial was conducted. 30 subjects were randomly divided into 3 groups in a ratio of 1:1:1. After an overnight fast, all subjects received a single dose administration of 320 mg ABT by intravenous drip for 45 min (Group A) or bolus injection for 0.5 min (Group B) or bolus injection for 3 min (Group C). ABT plasma concentrations were analyzed using validated enzyme-linked immunosorbent assay. Noncompartmental analysis was used to evaluate PK parameters.Results. The median value of time to reach maximum concentration was 0.75 h in group A and 0.16 h in both group B and C, elimination half-life, mean residence time, apparent clearance and apparent volume of distribution was similar among three groups. The 90% confidence intervals of geometric mean ratios of PK parameters for group B and C relative to group C are mainly within 85–120%. All AEs in this study were mild, according to the CTCAE guidelines and the study investigator’s judgement.Conclusion. ABT bolus injection for 0.5 min and 3 min are expected well tolerated and to have similar pharmacokinetic characteristics as IV drip for 45 min, thus offering potential clinical benefits.

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Section: Discussionmentioning

confidence: 77%

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

Qin

Cheng²,

Zhang

et al. 2023

Preprint

Self Cite

View full text Add to dashboard Cite

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“…The results are consistent with the TALENT study, 75.7% of study participants treated with ABT/LPV/r achieved HIV-1 RNA levels below 40 copies/mL after 48 weeks of treatment. [ 26 ] In another multicenter cohort study to assess DTG-based regimens in advanced HIV-infected naïve patients, the result demonstrated HIV-1 RNA < 40 copies/mL was achieved in 36% and 60% of individuals on DTG-based regimens at 1 month and 3 months, respectively. [ 27 ] High pretreatment HIV-RNA levels are also considered an independent predictor of delayed virological suppression, increased risk of virological failure, and subsequently increased risk of mortality.…”

Section: Discussionmentioning

confidence: 99%

Tolerability and effectiveness of albuvirtide combined with dolutegravir for hospitalized people living with HIV/AIDS

Liu,

He,

Yang

et al. 2023

Medicine

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Treatment options for hospitalized people living with HIV/AIDS (PLWHA) with opportunistic infections and comorbidities are limited in China. Albuvirtide (ABT), a new peptide drug, is a long-acting HIV fusion inhibitor with limited drug-drug interactions and fast onset time. This single-center, retrospective cohort study investigated the effectiveness and safety of ABT plus dolutegravir (DTG) therapy in a real-world setting. We performed a chart review on the electronic patient records for hospitalized PLWHA using ABT plus DTG between April and December 2020. The clinical outcomes were retrospectively analyzed. Among 151 PLWHA (mean age 47.6 ± 15.9 years), 140 (93%) had at least 1 episode of bacterial and/or fungal infections and 64 (42%) had other comorbidities including syphilis, hepatitis B, and/or hypertension. ABT plus DTG was given to 87 treatment-naïve (TN) and 64 treatment-experienced (TE) PLWHA. Regardless of treatment history, mean HIV-1 RNA levels significantly decreased from 4.32 log10copies/mL to 2.24 log10copies/mL, 2.10 log10copies/mL and 1.89 log10copies/mL after 2, 4 and 8 weeks of treatment, respectively (P < .0001). Compared with baseline mean CD4 + T-cell counts of 122.72 cells/μL, it increased to 207.87 cells/μL (P = .0067) and 218.69 cells/μL (P = .0812) after 4 and 8 weeks of treatment. Except for limited laboratory abnormalities such as hyperuricemia, increased creatinine level, and hyperglycemia observed after treatment, no other clinical adverse events were considered related to ABT plus DTG. Data suggests that ABT plus DTG is safe and effective for critically-ill hospitalized PLWHA. In view of the rapid viral load suppression and restoration of CD4 + count within 8 weeks of treatment, its clinical application warrants further investigation.

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Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

Qin

Cheng

Zhang

et al. 2023

Naunyn-Schmiedeberg's Arch Pharmacol

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Long-acting HIV fusion inhibitor albuvirtide combined with ritonavir-boosted lopinavir for HIV-1-infected patients after failing the first-line antiretroviral therapy: 48-week randomized, controlled, phase 3 non-inferiority TALENT study

Cited by 8 publications

References 7 publications

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

Tolerability and effectiveness of albuvirtide combined with dolutegravir for hospitalized people living with HIV/AIDS

Comparison of pharmacokinetics and safety of albuvirtide in healthy subjects after intravenous drip and bolus injection

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